化学发光免疫法分析孕妇血清甲状腺球蛋白抗体浓度分布及其对甲状腺球蛋白水平检测的影响研究

Study on the Distribution of Serum Thyroglobulin Antibody in Pregnant Women by Chemiluminescence Immunoassay and Its Interference on the Detection of Thyroglobulin

目的分析孕妇人群中甲状腺球蛋白抗体(thyroglobulin antibody,TgAb)的阳性率以及其体内不同浓度的TgAb对甲状腺球蛋白(thyroglobulin,Tg)检测的影响。方法回顾性分析2020年10月~2021年12月在西北妇女儿童医院门诊孕检的68955例孕妇血清TgAb和Tg的结果,并收集240份不同浓度TgAb的孕妇血清,进行Tg确证血清回收实验,分析不同浓度TgAb对Tg检测的影响。结果依据西门子检测系统的阳性结果判读标准(TgAb≥60IU/ml),68955例孕妇TgAb阳性率为15.47%(10665/68955),且TgAb阳性率随着孕妇年龄增长呈增高趋势(χ^(2)=101.931,P<0.001)。按照TgAb(IU/ml)<60(阴性),60~200,201~300,301~400,401~500和>500进行分组,其对应的Tg检测浓度(ng/ml)范围分别为11.26(2.87~43.80),3.40(0.13~63.95),3.15(0.15~70.70),0.60(0.13~50.92),0.59(0.14~64.22)和0.74(0.14~14.82)。Tg检测浓度与TgAb水平呈负相关(r=-0.504,P<0.001)。按照上述分组,其对应的Tg确证血清回收率分别为102.10%(81.09%~106.05%),97.03%(43.15%~109.29%),95.57%(41.67%~106.20%),84.57%(33.41%~105.25%),66.97%(29.33%~104.50%)和65.98%(21.70%~98.56%)。Tg确证血清回收率与TgAb水平呈负相关(r=-0.565,P<0.001)。Tg确证血清回收率小于80%的占比分别为0%(0/40),27.5%(11/40),35%(14/40),42.5%(17/40),62.5%(25/40)和67.5%(27/40)。孕妇不同TgAb浓度血清的Tg确证血清回收率小于80%的百分率差异有统计学意义(χ^(2)=51.134,P<0.001),且随着TgAb浓度的增高,呈增高趋势(χ^(2)=48.363,P<0.001)。结论当孕妇体内TgAb为阴性时,Tg的检测结果无影响;当TgAb阳性时,会干扰Tg检测,使其结果偏低,且浓度越高对Tg的干扰越强。由于孕妇群体TgAb阳性率较高,建议临床进行Tg检测时同时联合检测TgAb综合判断。

Objective To analyze the positive rate of thyroglobulin antibody(TgAb)in pregnant women and investigate the interference of different concentrations of TgAb in pregnant women on the detection of thyroglobulin(Tg).Methods The results of TgAb positive rate of 68955 pregnant women with pregnancy examination in Northwest Women’s and Children’s Hospital were analyzed retrospectively,from October 2020 to December 2021.240 samples of TgAb serum of pregnant women with different concentration levels were collected,and Tg confirmatory serum was added for recovery experiment.Results According to the result interpretation standard of Siemens detection system,the positive rate of TgAb(TgAb≥60IU/ml)in pregnant women was 15.47%(10665/68955),increasing with the age of pregnant women(χ^(2)=101.931,P<0.001).TgAb(IU/ml)concentrations were grouped according to<60(negative),60~200,201~300,301~400,401~500 and>500.Corresponding to different groups,Tg detection concentration ranges(ng/ml)were 11.26(2.87~43.80),3.40(0.13~63.95),3.15(0.15~70.70),0.60(0.13~50.92),0.59(0.14~64.22)and 0.74(0.14~14.82),and there was a significant negative correlation between the concentration of Tg and the level of TgAb,and the correlation coefficient was r=-0.504(P<0.001).The recovery rate of different TgAb concentrations of maternal serum was statistically different(P<0.001).According to the above grouping,the corresponding recovery rates of Tg confirmatory serum were 102.10%(81.09%~106.05%),97.03%(43.15%~109.29%),95.57%(41.67%~106.20%),84.57%(33.41%~105.25%),66.97%(29.33%~104.50%)and 65.98%(21.70%~98.56%),and Tg confirmed recovery rate was significantly negatively correlated with the level of TgAb,and the correlation coefficient was r=-0.565,P<0.001.The average recoveries less than 80%confirmed by Tg were 0%(0/40),27.5%(11/40),35%(14/40),42.5%(17/40),62.5%(25/40)and 67.5%(27/40),respectively.The percentage of recovery less than 80%of different concentrations of TgAb in maternal serum was statistically different(χ^(2)=51.134,P<0.001),and showed an increasing trend with the increase of TgAb concentration(χ^(2)=48.363,P<0.001).Conclusion When TgAb in pregnant women was negative,the detection results of Tg would be unaffected.When TgAb was positive,the higher the concentration,the stronger the interference to Tg,making the lower result.Due to the high positive rate of TgAb in pregnant women,it is recommended to jointly detect TgAb for comprehensive judgment during Tg testing.